Related Manuals for Advanced Bionics CI-5295
Summary of Contents for Advanced Bionics CI-5295
- Page 1 Sky CI M90 Sound Processor CI-5295 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, USA +1 661 362 1400 AdvancedBionics.com 029-M798-A2 Rev 1 2019-12-16...
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Page 2: Symbols Table
SYMBOLS TABLE: Labeling symbols and their meanings: Date of Manufacture Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF Suitable temperature range for transport and storage See Instructions for Use Fragile Suitable relative humidity range for transport and storage Caution (refer to “Cautions &... - Page 3 Do not use any other power supply with the sound processor or accessories unless it is supplied by Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement. Do not use accessories when they are plugged into power sources such as wall outlets, or other power sources that are USB compatible (e.g.
- Page 4 If the sound processor or accessories become unusually hot or warm, discontinue use immediately and contact Advanced Bionics or your cochlear implant professional. It is important to have the correct magnet strength, so you do not experience discomfort or retention issues.
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Page 5: Intended Use
Do not attempt to service or modify the Sky CI or its accessories. Doing so may compromise system performance and will void the manufacturer’s warranty. Products should be serviced only at Advanced Bionics and damaged products should be returned to Advanced Bionics. - Page 6 The intended users of the Sky CI M90 sound processor are recipients of Advanced Bionics cochlear implants. The intended use environments of the Sky CI M90 sound processor are healthcare and daily living environments. COMPATIBILITY: The Sky CI M90 is compatible with the following implant types from Advanced Bionics: ...
- Page 7 Powering Sky CI M90 The sound processor is turned on when a charged battery is attached to the sound processor. When the battery is first attached, the orange LED located in the middle of the rocker switch will indicate battery charge.
- Page 8 FPO Image Slide the battery onto the sound processor until it clicks into place. Do not force the battery onto the sound processor. The batteries are designed to be inserted in only one direction; applying force may damage the equipment. FPO Image Removing the Battery...
- Page 9 Hold the Sky CI M90 in one hand. In the other hand, hold the battery. Rotate the headpiece cable upward in order to avoid bumping it upon battery removal. FPO Image Firmly slide the battery away from the M T-Mic, M Earhook, or M Acoustic Earhook. FPO Image Continue sliding the battery until it separates from the sound processor.
- Page 10 FPO Image Approved Sky CI M90 Power Supplies Power Supply Nominal Voltage Type Rated Capacity M Battery 3.6V – 3.7V Li-ion (rechargeable) 0.3Wh – 0.8Wh M Waterproof Battery 3.7V Li-ion (rechargeable) 0.8Wh M Zn-Air Battery Pak 2.3V Zn-air (disposable) 1.4Wh Connecting the earhook to the sound processor There are three earhook options for the Sky CI M90 sound processor: the M T-Mic, the M Earhook, and the M Acoustic Earhook.
- Page 11 FPO Image Using the provided pin removal tool, place one of the pins in the small hole on the side of the tool. This will help to steady the pin as you line it up with the pin hole on the earhook. FPO Image Line up the pin with the hole in the earhook and gently push it through the hole.
- Page 12 If a small portion of the pin extends beyond the sound processor, use the side of the tool to push the pin inwards so it lies flush with the sound processor. FPO Image Pull the tool away from the sound processor, leaving the pin inside the sound processor. FPO Image...
- Page 13 Removing the earhook Align the pointed end of the tool with the hole on the sound processor that contains the pin holding the earhook on the sound processor. FPO Image Gently press the tool in the hole, pushing the pin out the other side. FPO Image...
- Page 14 The pin does not need to be removed from the sound processor. As long as the tool is pushed in flush on one side of the sound processor, the pin should be displaced enough to adequately remove the earhook. Remove the tool from the sound processor. Gently grasp the earhook at the top near where it connects with the sound processor and pull forward until it is separated from the sound processor.
- Page 15 To attach the headpiece cable to the sound processor, hold the headpiece cable by the cable’s strain relief. Align the connector on the cable with the connector on the sound processor and gently push the cable into the sound processor until it snaps into place. FPO Image Removing the Slim HP cable from the sound processor Remove the battery from the processor before removing the cable from the processor.
- Page 16 Sky CI M90 LEDs The LED is a programmable feature that provides visual information about the Sky CI M sound processor status, battery life, program position, and sound processor error conditions. Indication Color Behavior Programmable Battery Status at Start-Up Orange Blinks at start-up with use of rechargeable batteries (not available with M Zn-Air Battery...
- Page 17 per second) Error Condition (remove and Solid Red reattach battery to reset sound processor) Detect Sound Processor Green 3 blinks upon command from mobile application or fitting software Sky CI M90 Internal Alarms The internal alarms are programmable and provide auditory information about the Sky CI M90 sound processor.
- Page 18 Connectivity Overview The Sky CI M90 sound processor can be connected to Bluetooth-enabled devices for phone calls, VoIP calls, audio streaming, or for use with the AB Remote mobile application. Pairing and Connecting the Sky CI M90 to a Bluetooth-Enabled Device 1.
- Page 19 When the sound processor is directly connected with a Bluetooth-enabled phone, you will be able to hear the caller’s voice directly through the sound processor. The sound processor picks up your voice through the sound processor microphones. FPO Image When making a phone call, you will hear a dialing tone through the sound processor. The sound processor microphones pick up your voice.
- Page 20 FPO Image Streaming Audio via Bluetooth with the Sky CI M90 After successful pairing of your processor(s) to your Bluetooth-enabled device, ensure that your device is not muted and volume is not set to minimum. Then, simply start the audio on the Bluetooth-enabled device and the sound processor will start streaming the audio.
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Page 21: Care And Maintenance
Activating and Deactivating Flight Mode 1. Hold down either the top or bottom of the multifunction button while attaching the battery. 2. Continue to hold down the button while the sound processor starts up, until a long, solid orange LED is visible, approximately 10 seconds. Note that the start-up LEDs that indicate the battery life of the rechargeable battery and the program number will be seen before the long, solid orange flight mode LED. - Page 22 CI-5295-240 CLINICAL BENEFITS: Advanced Bionics has completed a confirmatory study of AutoSense OS on the Naída CI M90 sound processor. A total of 10 subjects were enrolled in a prospective study using a within-subjects repeated- measures design where each subject served as his/her own control. Five subjects used the M Acoustic Earhook, while the remaining 5 used the M T-mic and electrical stimulation only.
- Page 23 Sentences in Quiet at 65 dBA Across all subjects, similar sentence recognition scores in quiet were observed between AutoSense OS and the AutoSense OS Off program. See the table below. 2 List AutoSense OS 2 List AutoSense OS Off Average Score (%) Average Score (%) Mean (SD) 88.92 (11.068)
- Page 24 2) are able to report a preference for different coding strategies or features. ClearVoice is only available in markets where ClearVoice has received regulatory approval. Contact Advanced Bionics for more information. COUNSELLING AND FITTING RECOMMENDATIONS: ...
- Page 25 AutoSense Sky OS: The intent of the AutoSense Sky program is to classify the listening environment and activate sound processing features based on the listening environment. The AutoSense Sky program is enabled by default as the start-up program. Cautions ...
- Page 26 System and Network Diagram System Interfaces Component Interface Data Transfer Communication Protocol Security Direction Sound Bluetooth Bidirectional Bluetooth Classic: Hands- Bluetooth Classic: Processor Free Profile with E0 encryption wideband speech option Bluetooth LE: AES- v1.6 (SPP v1.2, RFCOMM CCM 128 v1.2 over L2CAP) encryption Bluetooth Classic:...
- Page 27 Advanced Bionics cochlear implant when fit with the Target CI fitting software. All events are logged to an internal event log. Advanced Bionics can interpret and analyze the log if the device is returned. Data integrity and quality of service is ensured through sound processor and implant error correction and detection mechanisms.
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Page 28: Guidance And Manufacturer's Declaration
Users of the Sky CI M90 sound processor are trained by their cochlear implant professional at the initial fitting session. End of Cybersecurity Support Advanced Bionics products are supported until they no longer have regulatory approval in the country of use or until the product is obsolesced by Advanced Bionics. GUIDANCE AND MANUFACTURER’S DECLARATION:... - Page 29 other electronic devices, precaution should be taken to not generate ESD. Power frequency (50/60 3 A/m 3 A/m Power frequency Hz) Magnetic Field magnetic fields should IEC 61000-4-8 be at levels characteristic of a typical location in a typical commercial or hospital environment.
- Page 30 symbol: Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Essential performance of the Sky CI per IEC 60601 requirements is defined as auditory stimulation within safe amplitudes.
- Page 31 2. This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Advanced Bionics may void the FCC authorization to operate this equipment. This Class B digital apparatus complies with Canadian ICES-003.
- Page 32 Brancher l’appareil sur un circuit électrique différent de celui où le récepteur est branché. Consulter votre professionnel de l’implant cochléaire ou un technicien spécialisé en radio/télévision pour obtenir de l’aide. © 2020 Advanced Bionics LLC. All Rights Reserved.